FDA Proposal: Allow Generic Drug Label Updates

The U.S. Food and Drug Administration (FDA) just issued a proposed rule to allow generic drug makers to update labels should they receive information on potential safety issues associated with their drugs.

Today, only brand name drug makers are permitted to make such label changes. The proposed rule, if approved, will also enable litigation to proceed against generic drug manufacturers, noted The New York Times.

The Supreme Court has ruled that, under state law, the makers of generic drugs may not be sued for adverse reactions allegedly associated with their products, finding that companies that produce branded drugs are liable for any inadequacies on their drugs warning labels, NBC’s Today News explained. Today, generic drug makers must simply ensure their drug labels mirror those of the related brand.

Dr. Janet Woodcock, FDA’s head of drug evaluation and research, stated that the proposed rule would create more equality between manufacturers of brand and generic medications, a key issue given that more than 80 percent of the prescriptions written in the United States are dispensed as generics, according to the Times. “Now, with the generic industry having grown up, most people are taking generic drugs,” she said in a telephone interview. “It’s really time to level the playing field.”

Upon approval of the proposed rule, patients alleging that their generically dispensed medication led to side effects that were not appropriately disclosed by the generic drug maker, may proceed with litigation, according to the Times. Advocates have expressed pleasure with the move, noting that today’s process is not fair to patients who have allegedly suffered injuries tied to generic drugs. “This is an important consumer protection provision,” said Representative Chris Van Hollen (Democrat-Maryland) who supports the move, “It’s a long time in coming,” he told the Times.

An overturned multi-million-dollar jury award had found for a very seriously injured patient who alleged that a generic drug she was prescribed was unsafe; however, the court ruled in favor of the generic drug manufacturer, according to Reuters.

Consumer watchdog group, Public Citizen, has said that the high court’s decision minimizes patient safety and that, with the overwhelmingly large percentage of generic prescriptions filled, the safety gap for patients is huge. Michael Carome, director of Public Citizen’s Health Research Group, said that, often, some possibly serious adverse reactions are not always seen, known, or understood for years—even tens of years—following FDA approval. This, often, is well after branded versions are no longer available, he noted, according to Reuters. “Ultimately, we believe that the generic companies need to be the ones who are primarily responsible for ensuring the safety of their products…. Right now, no one’s doing it adequately,” Dr. Carome told Reuters earlier this year.

The new rule, according to the FDA, would speed release of new “safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.” In the interim, the agency plans on developing a web page for drug makers’ safety-related change proposals; consumer may sign up to receive these updates.